Oxford BioMedica Notes the Longer-Term Analyses from Pivotal Kymriah® Trials, Which Showed Durable Responses Are Maintained in Patients with Advanced Blood Cancers
Oxford BioMedica plc (“Oxford BioMedica” or “the Group”) (LSE:OXB), a leading gene and cell therapy group, today notes an announcement by Novartis on the longer-term analyses of both the ELIANA and JULIET pivotal trials in children and young adult patients with relapsed or refractory (r/r) acute lymphoblastic leukaemia (ALL) and adult patients with r/r diffuse large B-cell lymphoma (DLBCL), respectively. Kymriah® (tisagenlecleucel) continued to demonstrate strong efficacy with durable responses and maintained a consistent and well-characterised safety profile. These data are being presented at the 60th American Society of Hematology (ASH) annual meeting. Additionally, today, the New England Journal of Medicine published online the 14-month results from JULIET, the study led by the Abramson Cancer Center at the University of Pennsylvania 1.
In the 24-month follow-up analysis of the ELIANA study in children and young adults with r/r B-cell ALL, Kymriah demonstrated deep and durable responses without subsequent therapy in a significant portion of patients in this population. Among 79 evaluable patients, who were followed for at least three months or discontinued earlier, 82% (95% confidence interval [CI], 72% - 90%) achieved complete response (CR) or CR with incomplete blood count recovery (CRi) within three months of infusion; and among these responding patients, 98% had negative minimal residual disease (MRD). The relapse-free survival rate was 62% at 24 months; and the median duration of remission (mDOR) and median overall survival (mOS) remained unreached, signifying responses are deep and sustained, and further reinforcing the potential for Kymriah to be a definitive therapy for many patients. The probability of OS was 76% (95% CI, 65% - 85%) at 12 months and 66% (95% CI, 58% - 79%) at 24 months. The safety profile observed in this updated analysis was consistent with previously reported results, with no emergence of new safety signals. Grade 3/4 cytokine release syndrome (CRS) – as defined by the rigorous Penn Grading Scale – occurred in 49% of patients. Within eight weeks of infusion, 13% of patients experienced grade 3 neurological events, with no grade 4 events or cerebral oedema2. These updated data will be presented in an oral session at the ASH annual meeting (Abstract # 895; Monday, December 3, 4:30PM PST).
Results from the 19-month analysis from the JULIET study of Kymriah in adult patients with r/r DLBCL (n=99) indicated prolonged durability of response in patients who had previously been through multiple rounds of chemotherapy and unsuccessful stem cell transplants (Abstract # 1684). The overall response rate (ORR) after a median of 19 months of follow-up was 54% (95% CI, 43% - 64%; CR, 40%; partial response [PR], 13%) among patients who were followed for at least 3 months or discontinued earlier. The mDOR was not reached at the time of analysis indicating most responders were still experiencing a response at the time of analysis; and the relapse-free probability, which was 66% (95% CI, 51%-78%) at 6 months, remained consistent at 64% (95% CI, 48%-76%) between 12-month and 18-month analyses. Further, 54% (15/28) of patients who had achieved a PR converted to CR. Median OS for all infused patients was 11.1 months (95% CI, 6.6 months-NE) and not reached (95% CI, 21 months-NE) for patients in CR. The OS probability was 48% (95% CI, 38%-57%) at 12 months and 43% (95%CI, 33%-53%) at 18 months (max follow-up, 29 months). Analyses of ORR, DOR and OS data showed consistent results across all patient subgroups, regardless of relapsed/refractory status, age and high-risk cytogenetics.
The safety profile observed in the 19-month follow-up from JULIET continued to be consistent with previous reports and no deaths occurred due to causes other than disease progression in this longer-term follow up analysis. Within eight weeks of infusion with Kymriah, Grade 3/4 CRS, as defined by the Penn Grading Scale, was reported in 23% of patients. CRS management was conducted per the Penn CRS management algorithm, which is specific to Kymriah. Tocilizumab and steroids were used in 16% and 11% of patients, respectively, to treat CRS. Eleven percent of patients had Grade 3/4 neurologic adverse events, which were managed with supportive care3.
Oxford BioMedica is the sole manufacturer of the lentiviral vector used in Kymriah. The Group signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate Kymriah and other undisclosed CAR-T products. This collaboration has reached important milestones in 2018 with the US FDA approval of Kymriah to treat adult patients with r/r DLBCL, and the approval of Kymriah in these two distinct indications in the European Union, Canada and Switzerland. These important achievements follow the initial US launch of Kymriah in paediatric and young adult patients with r/r B-cell ALL in 2017. Oxford BioMedica signed an agreement with Novartis in July 2017 for the commercial and clinical supply of lentiviral vectors used to generate CTL019 and other undisclosed CAR-T products, for which Oxford BioMedica could potentially receive in excess of $100m from Novartis over the next three years.
Notes for editors
About the ELIANA Trial
ELIANA is the first paediatric global CAR-T cell therapy registration trial, examining patients in 25 centres in 11 countries across the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain, demonstrating effective distribution of Kymriah across four continents using a global supply chain. In 2012, Novartis and Penn entered into a global collaboration to further research, develop and commercialize CAR-T cell therapies, including Kymriah, for the investigational treatment of cancers.
About the JULIET Trial
JULIET is the first multi-centre global registration study for Kymriah in adult patients with r/r DLBCL. JULIET, led by researchers at the University of Pennsylvania, is the largest and only global registration study examining a CAR-T cell therapy in DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and Europe, including Austria, France, Germany, Italy, Norway and the Netherlands.
In August 2017, Kymriah became the first available chimeric antigen receptor T cell (CAR-T) therapy when it received FDA approval for children and young adults with B-cell acute lymphoblastic leukaemia (ALL) that is refractory or has relapsed at least twice. Kymriah is a novel immunocellular therapy and a one-time treatment that uses a patient’s own T cells to fight cancer. Kymriah uses the 4-1BB costimulatory domain in its chimeric antigen receptor to enhance cellular expansion and persistence.
About Oxford BioMedica
Oxford BioMedica (LSE:OXB) is a leading gene and cell therapy group focused on developing life changing treatments for serious diseases. Oxford BioMedica and its subsidiaries (the "Group") have built a sector leading lentiviral vector delivery platform (LentiVector®), which the Group leverages to develop in vivo and ex vivo products both in-house and with partners. The Group has created a valuable proprietary portfolio of gene and cell therapy product candidates in the areas of oncology, ophthalmology and CNS disorders. The Group has also entered into a number of partnerships, including with Novartis, Bioverativ, Sanofi, Axovant, Orchard Therapeutics, Boehringer Ingelheim/UK Cystic Fibrosis Gene Therapy Consortium/Imperial Innovations and GC LabCell, through which it has long-term economic interests in other potential gene and cell therapy products. Oxford BioMedica is based across several locations in Oxfordshire, UK and employs more than 360 people. Further information is available at www.oxb.com.
|1 Schuster S., et. al. Tisagenlecleucel in Adult Relapsed/Refractory Diffuse Large B-Cell Lymphoma. New England Journal of Medicine. December 2018.|
|2 Grupp S., et al. Updated Analysis of the Efficacy and Safety of Tisagenlecleucel in Pediatric and Young Adult Patients with Relapsed/Refractory (r/r) Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #112599.|
|3 Schuster S., et. al. Sustained Disease Control for Adult Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma: An Updated Analysis of Juliet, a Global Pivotal Phase 2 Trial of Tisagenlecleucel, Acute Lymphoblastic Leukemia. 60th American Society of Hematology Annual Meeting and Exposition. Abstract #: 11525.|
Oxford BioMedica plc:
John Dawson, Chief Executive Officer
Stuart Paynter, Chief Financial Officer
Sarah MacLeod, Head of Communications
Tel: +44 (0)1865 783 000
Consilium Strategic Communications
Mary-Jane Elliott/Matthew Neal/Laura Thornton
Tel: +44 (0)20 3709 5700
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Akaal Pharma Pty Ltd Announces Licensing Agreement for its First-in-Class, Topical Spingosine-1-Phosphate-1 (S1P1) Receptor Modulator for Atopic Dermatitis and Psoriasis18.12.2018 23:56 | Pressemelding
Akaal Pharma Pty Limited (Akaal Pharma) today announced that it has entered into a licensing agreement for Akaal Pharma’s First-in-Class, topical Spingosine-1-Phosphate-1 (S1P1) modulator, AKP-11, with Boston Pharmaceuticals, Inc. (Boston Pharmaceuticals). AKP-11 is a differentiated S1P1 modulator, which potentially has clinical applications in a number of inflammatory, immune and vascular diseases. Akaal Pharma has demonstrated the clinical activity of AKP-11 in multiple Phase-1 clinical studies. Under the terms of the license, Boston Pharmaceuticals is responsible for the further clinical development and commercialisation of AKP-11 for the Americas and Europe. Akaal Pharma has the rights for the rest of the world. Financial terms of the agreement were not disclosed. "We continue to actively prioritize and expand our dermatology and pain programs to serve the wider global community suffering from these diseases and where there is need of safe and effective treatment,” said Chairman of
Takeda Announces Listing of American Depositary Shares on the New York Stock Exchange18.12.2018 22:33 | Pressemelding
NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION Takeda Pharmaceutical Company Limited (TSE: 4502) (“Takeda”) today announced that the listing and trading of its American Depositary Shares (“ADSs”) on the New York Stock Exchange (“NYSE”) is expected to commence on December 24, 2018. Takeda’s ADSs currently trade over-the-counter. The ADSs will now trade under the ticker symbol “TAK” and The Bank of New York Mellon will continue to act as the depositary bank for the ADS program. Takeda will maintain its headquarters in Japan and its primary listing on the Tokyo Stock Exchange (the “TSE”), as well as its current listings on local Japanese stock exchanges. “Our dual listing on the NYSE and TSE reflects our position as a leading global biopharmaceutical company and will provide wider capital markets access with expanded trading hours for our in
Sestek Speech Analytics Scores the Highest Overall Vendor Satisfaction Mark from Customers in DMG Consulting Survey18.12.2018 19:00 | Pressemelding
Sestek today announced that it was recognized for getting the highest overall vendor satisfaction rating from customers in DMG Consulting’s 2018 – 2019 Speech Analytics Product and Market Report. Compared to the featured competitors, Sestek Speech Analytics achieved the highest customer ratings in 8 major vendor categories out of 10. Here are the 7 categories in which Sestek Speech Analytics received a perfect score of 5.0 by the customer satisfaction ratings: • Training and workshops • Ongoing service and support • Professional services • Innovation • Responsiveness to product enhancement requests • Vendor communication • Overall vendor satisfaction Donna Fluss, the President of DMG Consulting -providing comprehensive coverage and authoritative analysis for the market- stated the importance of speech analytics: “Speech analytics has always been interesting because of its unique contributions to the understanding of voice interactions in the contact center. Companies that invest in the
Brand Marketing and Social Purpose Veteran Larry Koffler Joins BCW18.12.2018 18:31 | Pressemelding
BCW (Burson Cohn & Wolfe), a leading global communications agency, today announced that Larry Koffler has joined as Executive Vice President, Managing Director in the agency’s Brand Solutions Practice in New York. He will join BCW on January 14, 2019. “Larry has had an extraordinary career leading integrated communications programs that bridge brand, corporate and purpose for some of the world’s most iconic brands and organizations,” said Chris Foster, President, North America, BCW. “His award-winning experience across a wide variety of industries will be invaluable to clients – and in particular purpose-driven clients – that need powerful programs that exceed expectations and drive meaningful results. I am excited for what he will add to BCW’s celebrated brand solutions business.” Koffler will report to Thomas Bunn, Executive Vice President, Managing Director, Brand Solutions. Koffler joins BCW from Edelman, where he spent the entirety of his career and most recently served as Executi
Skitude Premium Launches, Offering Personalised 3D Mapping, 3D Tracks, Advanced Statistics, Speed Heat Maps and Apple Watch Compatibility18.12.2018 15:58 | Pressemelding
Skitude, the world’s largest apps community of digitally-connected snow sport lovers, with over a million users, has launched a premium version of its popular profile. Skitude apps are available for Android and Apple devices, and the premium upgrade offers the option to see your day’s skiing/boarding as an interactive 3D map, a speed ‘heat map’ or by statistical analysis of descents, slopes and distances covered. There is also Apple Watch compatibility, so your smartphone battery won’t be dead by lunchtime, as can often be the case with tracking apps. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181218005591/en/ (Photo: Skitude) Premium also offers 3D maps and advanced statistics for over 2,500 resorts worldwide, with real time information on slope conditions and whether runs are open. There are ‘points of interest’, webcams and a wealth of other useful information to help you make the most of your time on the slopes. Skit
PSB Names Mike Chuter Chief Executive Officer18.12.2018 14:15 | Pressemelding
PSB, a global research-based consultancy within BCW, announced today that Mike Chuter has joined the firm as Chief Executive Officer, effective immediately. Chuter is based in New York and reports to Donna Imperato, Global CEO of BCW. He is responsible for the global growth and development of the organization across its Corporate, Political, Media and Entertainment practices. “Mike is exceptionally well-suited to lead PSB given his deep experience interpreting data through both analytical and creative lenses and in driving integrated communications programs rooted in analytics,” said Imperato. “Mike is the right person to help PSB advise on holistic creative communications solutions that leverage the firm’s industry-leading expertise in primary research and behavioral, social and other third-party data analysis.” Chuter is a 25-year agency veteran who joins PSB from global social impact organization Thankful, which he co-founded in 2013, a one-half commercial enterprise, one-half socia